Ulnar Osteotomy Compression Plate, Short Model: UOCP-S
TriMed Inc. began a recall of Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical... on . FDA classified it as Class II and gives the reason as "Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2877-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Trimed Inc
- Product
- Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
- Product code
- HRS Plate, Fixation, Bone
- Reason for recall
- Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Tri-Med issued notification on April 16, 2018 requesting: Determine the lot number of all Ulnar Osteotomy Compression Plates, Short (UOCP-S) .If you have UOCP-S plates with the lot numbers listed (10003, 10017): o Remove the UOCP-S plates from the tray and quarantine it. Do not use this plate. Contact TriMed at [email protected] or call 800-633-7221. TriMed will arrange have the plate(s) returned to the company and replaced. Return the Recall Response card attached to this letter to TriMed as soon as possible. Contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221, Email: [email protected]. TriMed will replace the potentially defective plates with plates that have been manufactured and confirmed to meet TriMeds specifications.
- Quantity in commerce
- 722
- Distribution
- Worldwide Distribution in the state of TX and countries of Australia, China Sweden
- Product codes and lots
- Lot Numbers: 10003, 10017
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2877-2018 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
